Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy (CMR-ICD)

Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.

Study Overview

• Status: Recruiting
• Conditions: Non-ischemic Dilated Cardiomyopathy
• Intervention / Treatment: Other: ICD/CRT-D implantation

Detailed Description

The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.

• Study Type: Interventional
• Enrollment (Estimated): 760
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingo Eitel, Prof. Dr.; Phone Number: +49 451 500 44501; Email: ingo.eitel@uksh.de
• Study Contact Backup: Name: Thomas Stiermaier, Dr.; Phone Number: +49 451 500 44501; Email: thomas.stiermaier@uksh.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Universität zu Lübeck
      • Contact: Ingo Eitel, Prof. Dr. med.
      • Contact: Thomas Stiermaier, Dr.med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• NIDCM (idiopathic or familial)*
• LVEF ≤35% and presence of fibrosis on CMR
• Diagnostic CMR scan
• Age ≥18 years
• Written informed consent
• Ability to give informed consent

Exclusion Criteria:

• ICM [previous myocardial infarction, previous percutaneous coronary intervention]
• Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy].
• Myocarditis
• Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
• Severe renal insufficiency (creatinine clearance <30 mL/min)
• Current pacemaker or defibrillator in situ
• Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)
• Renal impairment defined as an eGFR <30 milliliters
• Age <18 years
• Patients presenting with pregnancy
• Patients without informed consent
• Participation in another randomized trial
• Life expectancy <2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICD group; Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated.	Other: ICD/CRT-D implantation; ICD/CRT-D implantation (if indicated)
No Intervention: Optimal HF care group; Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death from any cause	Death from any causes during follow-up - after discharge.	Day 0

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Ingo Eitel
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Principal Investigator: Ingo Eitel, Prof. Dr., Medical Clinic II - University Heart Center Lübeck

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 20-275; CMR-ICD-DZHK23 (Other Identifier: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No